The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Sefria Methamphetamine Oral Fluid Enzyme Immunoassay.
| Device ID | K203647 |
| 510k Number | K203647 |
| Device Name: | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Contact | Wenying (jessica) Zhu |
| Correspondent | Elina Arroyo Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Product Code | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-14 |
| Decision Date | 2021-12-22 |